Postprocedural Delayed Gastric EmptyingElentalNCT01467765
The Effect of Elemental Diet on Gastric Emptying
A study testing Elental in people with Postprocedural Delayed Gastric Emptying, run by Showa Inan General Hospital at 1 site in Japan.
Trial summary
In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postprocedural Delayed Gastric Emptying
- What is being tested?
- Elental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- percutaneous endoscopic gastrostomy patients
Who cannot join
- history of abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy
In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.
- Conditions
- Postprocedural Delayed Gastric Emptying
- Being tested
- Elental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElentalOther
200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
| Study group | Role | What they receive |
|---|---|---|
| Elemental diet | Active comparator | Not described Receives: Other: Elental |
| Liquid nutrient | Placebo comparator | Not described Receives: Other: Elental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gastric emptying
Two kinds of liquid test meals (Elemenal diet or regular liquid nutrient ) (200kcal/200ml) labeled with 100 mg(13C sodium acetate) are administered for 15 min and after that 13C breath test performed during the 4 hours
Measured: Four hours (from 7:30 am to 11:30 am)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprocedural Delayed Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467765
- Sponsor's protocol ID
- Elental study
- Acronym
- Elental
- Status last verified
- Aug 2012
- First submitted
- 5 Nov 2011
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study of Elemental Diet and Regular Liquid Diet on Gastric Emptying in Patients With Percutaneous Endoscopic Gastrostomy
- ClinicalTrials.gov ID
- NCT01467765
- Acronym / sponsor ID
- Elental / Elental study
- Conditions
- Postprocedural Delayed Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elemental diet | Active comparator | Other: Elental |
| Liquid nutrient | Placebo comparator | Other: Elental |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- percutaneous endoscopic gastrostomy patients
Key exclusion criteria (1 listed)
- history of abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elental200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients | Other | Elemental diet, Liquid nutrient |
Primary outcome
Measurement of gastric emptying
Time frame: Four hours (from 7:30 am to 11:30 am)
Two kinds of liquid test meals (Elemenal diet or regular liquid nutrient ) (200kcal/200ml) labeled with 100 mg(13C sodium acetate) are administered for 15 min and after that 13C breath test performed during the 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
Related trials for Postprocedural Delayed Gastric Emptying
Recruiting
Acupuncture for Postoperative Gastric Emptying Delay
Gastroparesis Postoperative, Delayed Gastric Emptying Following Procedure
Active, not recruiting
Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity
Obesity, Weight Loss
RecruitingObservational study
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Obesity, Obesity, Morbid
RecruitingPhase 2/3
Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
Esophageal Cancer Surgery, Esophagectomy
Enrolling by invitationObservational study
Endoscopic Metabolic and Bariatric Therapies
Obesity, Obesity, Morbid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elental in people with Postprocedural Delayed Gastric Emptying, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of gastric emptying (time frame: Four hours (from 7:30 am to 11:30 am)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012.